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Health product recall

Cepacol Extra Strength Cherry

Starting date:
February 20, 2013
Posting date:
April 2, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs, Natural health products
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-26473

Recalled Products

  1. Cepacol Extra Strength Cherry

Reason

Stability failure at the 18-month time point for free benzocaine potency.

Depth of distribution

Distributed to wholesalers and retailers across Canada.

Affected products

A. Cepacol Extra Strength Cherry

DIN, NPN, DIN-HIM

NPN 80032140

Dosage form
  • Lozenge
Strength
  • 4-Aminobenzoic acid, ethyl ester 15.0mg
  • L-Menthol 3.6mg
Lot or serial number
  • AG376
  • AH387
  • AK063
  • AL368
Companies
Recalling Firm

Reckitt Benckiser Ltd.

8020 Esquesing Line

Milton

L9T 6W3

Ontario

CANADA

Marketing Authorization Holder

Reckitt Benckiser Ltd.

8020 Esquesing Line

Milton

L9T 6W3

Ontario

CANADA